Role OverviewThe Senior Specialist, Regulatory Affairs will be responsible for understanding the development of medical devices as applicable to combination products and ensuring regulatory strategies are applied to regulatory submission documents to meet program requirements. This position includes supporting internal and external customer regulatory requests. The role requires a minimum of 3 days per week on-site and no relocation is provided.
What You Will Do
Implement regulatory strategies for medical devices and combination products, prepare submission sections for new products, product changes, and information requests, and provide guidance to global cross-functional teams. The Senior Specialist will also review change controls, support the EU RA office with complaints and Post Market Surveillance, and maintain proficiency in worldwide regulatory requirements.
Why It Might Be a Fit
The ideal candidate will have a strong understanding of US FDA regulations, EU MDD, and MDR, as well as experience with interactions with government agencies. The role requires technical leadership skills, negotiation and decision-making skills, and excellent oral communication and technical writing skills.
Requirements
- Bachelor's Degree in science, math, engineering, or related discipline required
- Minimum 5 years of experience with Bachelor’s degree or Minimum 2 years of experience with Master’s degree/PhD in medical device regulatory required
- US Class II and EU Class IIa device experience and knowledge of US FDA regulations (Title 21), EU MDD (93/42/EEC) and MDR (2017/745), 21 CFR 820, 210, 211 and ISO 13485
- Regulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferred
Benefits
- Benefit programs to empower physical, mental, emotional, and financial health
- Sustainability efforts to create a healthier environment and planet
- Opportunities for lifelong learning, growth, and development
- Equal opportunity employer and value diversity at the company
]]>